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February 27, 2013
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  Today's Top Story 
  • Analysis: Recall could make FDA more cautious about biosimilars
    The recall of Affymax's anemia drug Omontys could prompt more caution from the FDA as it develops a pathway for the approval of biosimilar drugs, former FDA official Dr. Scott Gottlieb writes. "The agency has years of experience with biological agents that simulate red blood cell production, and the inability to ferret out the risks with Omontys is likely to underscore how hard this science remains," he writes. Forbes (2/25) LinkedInFacebookTwitterEmail this Story
Breast-Case Scenario: Kadcyla Price Set at Premium to Others
The FDA’s approval of T-DM1 surprised few, though the price tag, box warnings and brand name Kadcyla may have raised some eyebrows. An antibody drug conjugate (ADC) that pairs Herceptin (trastuzumab) with ImmunoGen Inc.’s DM1 maytansinoid cell-killing agent to treat HER2-positive metastatic breast cancer will cost $9,800 per month. Find out the details.

  Health Care & Policy 
  • Biocare gets distribution rights to p63 technology
    Ventana Medical Systems and Biocare Medical reached a deal on the non-exclusive, worldwide rights to distribute the p63 mouse monoclonal primary antibody for research and in vitro diagnostics purposes. The agreement is connected with a settlement between Biocare and AsymmetRx Medical. "Including p63 in our lung, prostate and breast panels really empowers our Multiplex IHC platform to aid pathologists in making critical decisions," Biocare President and CEO Roy Paxton Yih said. GenomeWeb Daily News (free registration) (2/26) LinkedInFacebookTwitterEmail this Story
  • Genetic screening helps early trials of cancer drugs
    More efficient early-stage studies, advanced genetic screening and the need for better drugs have helped a few cancer treatments obtain faster approval in the past two years. "We hope to be able to shave years off the time it takes to get final approval and save hundreds of millions of dollars per drug," the New York University Cancer Institute's Robert Schneider said. Reuters (2/25) LinkedInFacebookTwitterEmail this Story
  • FDA stops trials of Amgen's Sensipar after teen's death
    The FDA halted all clinical trials of Amgen's Sensipar involving children following the death of a 14-year old. The agency said it is not sure whether Sensipar, which is approved for the reduction of blood calcium levels in adults, had a role in the death. "Amgen is working as rapidly as possible to understand the circumstances of what happened. This analysis is ongoing and will be concluded as quickly as possible," the firm said. Reuters (2/26) LinkedInFacebookTwitterEmail this Story
  Company & Financial News 
  Food & Agriculture 
  • DuPont Pioneer working on biotech wheat
    DuPont Pioneer is looking to develop a more disease-resistant, drought-tolerant and higher-yielding wheat using biotechnology and other tools. The firm put the hybrid wheat project on its list of crop research programs slated for deeper development. "We have an opportunity now with the technology," said John Soper, vice president for crop genetics/research and development. Reuters (2/26) LinkedInFacebookTwitterEmail this Story
  Industrial & Environmental 
  • Minn. bill would open door to more kinds of biofuels
    Minnesota lawmakers are considering legislation that would change the word "ethanol" in the state's renewable fuels policy to "biofuels" to make room for butanol and other bio-based fuels. The measure would also set an "aspirational goal" of having 30% biofuel content in the state's fuel supply by 2025. "The intent is to open the door to the use of more ethanol and the use of more biofuels of all kinds," said Tim Rudnicki, executive director of the Minnesota Bio-Fuels Association. Pioneer Press (St. Paul, Minn.) (2/26) LinkedInFacebookTwitterEmail this Story
  News from BIO 
  • BIOtechNOW
    BIOtechNOW is the first in a number of new products from BIO intended to enhance our communications with the biotech community -- not only with our members, but with other stakeholders as well. This e-newsletter, combined with its website, serves as our flagship in that effort. BIOtechNOW will offer original content that emphasizes the business needs of the industry; highlight BIO's advocacy efforts; and provide a portal to all BIO activities and events. Most importantly, it will spotlight for those outside the industry the value of biotechnology. Sign up for the e-newsletter. LinkedInFacebookTwitterEmail this Story
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--Kurt Lewin,
German-American psychologist

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